BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 20773961 · Received November 25, 2024

    Report

    Report Number
    0002023141-2024-03843
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    August 26, 2024
    Report Date
    March 20, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020047
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER - (B)(4). A4: WEIGHT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K013227. PRODUCT HAS BEEN RECEIVED BY ZIMVIE AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA, ADDITIONAL INFORMATION AND DEVICE EVALUATION. CORRECTION: THE REPORTED CATALOG NUMBER WAS UPDATED TO TSVWB10, THE LOT NUMBER WAS UPDATED TO 1284731, THE UDI NUMBER WAS UPDATED TO (B)(4), THE EXPIRATION DATE WAS UPDATED TO JULY 16, 2029, THE MANUFACTURE DATE WAS UPDATED TO JULY 17, 2024 AND THE PMA/510K NUMBER WAS UPDATED TO K061410/K011028/K013227. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. B5: EVENT DESCRIPTION WAS UPDATED. D4: CATALOG NUMBER, UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, LOT NUMBER AND EXPIRATION DATE WERE UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G4: PMA/510(K) NUMBER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H4: DEVICE MANUFACTURE DATE WAS UPDATED. H6: COMPONENT CODE WAS UPDATED: 887 H6: TYPE OF INVESTIGATION CODES WERE ADDED: 4109, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 3252. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 4307. H10: NARRATIVE/DATA WAS UPDATED. ZIMVIE RECEIVED THE REPORTED IMPLANT FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE. THE IMPLANT'S HEX WAS NOT STRIPPED OR DAMAGED, ONLY MINOR APPARENT DEBRIS WERE SEEN ATTACHED TO BOTH THE EXTERNAL AND INTERNAL THREADS. HOWEVER, THE CUSTOMER RETURNED THE BUNDLE MOUNT THAT WAS FRACTURED AT THE HEX. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE INCORRECT TECHNIQUES USED DURING PLACEMENT / EXCESSIVE TORQUE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #18 WAS PLACED AND WHEN THE DOCTOR WENT TO REMOVE THE IMPRESSION POST (MOUNT), THE HEX OF THE IMPLANT WAS STRIPPED. THE IMPLANT WAS REMOVED AND A NEW IMPLANT WAS PLACED.

    Description of Event or Problem · 0

    UPON FOLLOW UP WITH THE CUSTOMER, THE ITEM NUMBER AND LOT NUMBER WERE UPDATED. IN ADDITION, THE CUSTOMER STATED THAT THE HEX OF THE IMPLANT COULD HAVE BEEN FRACTURED AS THEY HAD A HARD TIME REMOVING IT. THE IMPLANT LOOKED DAMAGED SO THEY REPLACED IT IN THE SAME PROCEDURE WITH A NEW IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630580 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1284731 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male